US20150209559A1 - Weeping balloon catheter with drug delivery balloon in fluid communication with combination lumen - Google Patents
Weeping balloon catheter with drug delivery balloon in fluid communication with combination lumen Download PDFInfo
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- US20150209559A1 US20150209559A1 US14/680,134 US201514680134A US2015209559A1 US 20150209559 A1 US20150209559 A1 US 20150209559A1 US 201514680134 A US201514680134 A US 201514680134A US 2015209559 A1 US2015209559 A1 US 2015209559A1
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- lumen
- wire guide
- balloon
- drug delivery
- weeping
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0035—Multi-lumen catheters with stationary elements characterized by a variable lumen cross-section by means of a resilient flexible septum or outer wall
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/091—Guide wires having a lumen for drug delivery or suction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
- A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1061—Balloon catheters with special features or adapted for special applications having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1063—Balloon catheters with special features or adapted for special applications having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
Abstract
A weeping balloon catheter includes a catheter having an elongate tubular body defining an inflation lumen and a combination lumen that terminates at an open distal end of the elongate tubular body. A dilation balloon is disposed at a distal end of the elongate tubular body and is in fluid communication with the inflation lumen. A drug delivery balloon is disposed at least partially over the dilation balloon and includes at least one drug release opening through an outer wall of the drug delivery balloon. The drug delivery balloon is in fluid communication with the combination lumen through a sidewall opening of the elongate tubular body.
Description
- The present disclosure relates generally to a weeping balloon catheter and more particularly to a weeping balloon catheter having a drug delivery path defined by a combination lumen and a drug delivery balloon.
- Catheters provide minimally invasive means for treating various conditions. For example, angioplasty is a common procedure used to treat cardiovascular disease. During an angioplasty procedure, a medical device, such as a balloon catheter, may be percutaneously inserted into a vessel narrowed by stenosis. The balloon may be expanded at the stenosis to ultimately restore blood flow through the vessel. In some cases, a stent may be placed at the narrowed portion of the vessel to help keep the vessel open. In either case, it may be desirable to combine the balloon and/or stent treatment with the application of therapeutic drugs. In particular, it may be desirable to deliver a therapeutic drug exclusively to the narrowed portion of the vessel. In some cases, a therapeutic drug may be used to reduce restenosis at the treatment site.
- A number of catheter devices have been developed to administer a therapeutic agent locally to tissue while dilating a body vessel, such as during delivery of a therapeutic agent to a dilated portion of a coronary artery in an angioplasty procedure. For instance, U.S. Pat. No. 8,182,446 to Schaeffer et al. discloses a catheter having a dual balloon assembly. The dual balloon assembly includes an inner balloon and a porous outer balloon concentrically arrayed around the inner balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a vessel, where a therapeutic agent may be delivered from the catheter through apertures in the outer balloon. Such a balloon catheter device is also referred to as a weeping balloon. Weeping balloons typically require a profile size sufficient to accommodate a wire guide lumen, an inflation lumen, and a drug delivery lumen. Although weeping balloons have definite advantages, it should be appreciated that there is a continuing need for improved catheter devices.
- The present disclosure is directed toward one or more of the problems or issues set forth above.
- In one aspect, a weeping balloon catheter includes a catheter having an elongate tubular body defining an inflation lumen and a combination lumen that terminates at an open distal end of the elongate tubular body. A dilation balloon is disposed at a distal end of the elongate tubular body and is in fluid communication with the inflation lumen. A drug delivery balloon is disposed at least partially over the dilation balloon and includes at least one drug release opening through an outer wall of the drug delivery balloon. The drug delivery balloon is in fluid communication with the combination lumen through a sidewall opening of the elongate tubular body.
- In another aspect, a method of operating a weeping balloon catheter is provided. The weeping balloon catheter includes a catheter having an elongate tubular body defining an inflation lumen and a combination lumen that terminates at an open distal end of the elongate tubular body. The weeping balloon catheter also includes a dilation balloon disposed at a distal end of the elongate tubular body and in fluid communication with the inflation lumen, and a drug delivery balloon disposed at least partially over the dilation balloon and including at least one drug release opening through an outer wall of the drug delivery balloon. The drug delivery balloon is in fluid communication with the combination lumen through a sidewall opening of the elongate tubular body. The method includes steps of advancing the combination lumen over a wire guide toward a target site within a body lumen, and advancing a therapeutic agent along a drug delivery path defined by a first clearance between the wire guide and a wall of the combination lumen and the drug delivery balloon. The method also includes releasing the therapeutic agent from the drug delivery balloon at the target site.
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FIG. 1 is a partially sectioned side diagrammatic view of a weeping balloon catheter, according to one embodiment of the present disclosure; -
FIG. 2 is a cross sectional view taken along lines 2-2 ofFIG. 1 ; -
FIG. 3 is a cross sectional view taken along lines 3-3 ofFIG. 1 ; -
FIG. 4 is a cross sectional view taken along lines 3-3 ofFIG. 1 , depicting a reduced clearance between a wire guide and a wall of the combination lumen; -
FIG. 5 is an alternative cross sectional view of a dual lumen catheter portion of a weeping balloon catheter, according to the present disclosure; -
FIG. 6 is another alternative cross sectional view of a dual lumen catheter portion of a weeping balloon catheter, according to the present disclosure; -
FIG. 7 is a side diagrammatic view of a vascular structure of a patient depicting one stage of a treatment procedure using the weeping balloon catheter ofFIG. 1 ; -
FIG. 8 is a side diagrammatic view of the vascular structure at another procedure stage; -
FIG. 9 is a side diagrammatic view of the vascular structure at another procedure stage; -
FIG. 10 is a cross sectional view of a specialty wire that may be used with the weeping balloon catheter of the present disclosure; and -
FIG. 11 is a side view of another specialty wire that may be used with the weeping balloon catheter of the present disclosure. - Referring to
FIG. 1 , there is shown aweeping balloon catheter 10 according to one embodiment of the present disclosure. Theweeping balloon catheter 10 generally includes acatheter 12 having an elongatetubular body 14 having aproximal end 16 and adistal end 18. The elongatetubular body 14 may be made from any common medical tube material, such as, for example, polytetrafluoroethylene (PTFE), high density polyethylene (HDPE), nylon, polyetheretherketone (PEEK), or any vinyl, plastic, rubber, or silicone, and may exhibit both stiffness, or firmness, and flexibility. Materials as well as dimensions may vary depending on the particular application. In the present disclosure, “proximal” will be used to refer to the end of a component or feature that is closest to a clinician, while “distal” is used to refer to a component or feature that is farthest away from the clinician. Such meanings are consistent with conventional use of the terms and, as such, should be understood by those skilled in the art. - The elongate
tubular body 14 defines aninflation lumen 20 extending from theproximal end 16 to adilation balloon 22 disposed, or mounted, at thedistal end 18 of the elongatetubular body 14. Theinflation lumen 20 may be in fluid communication with aninterior space 24 of thedilation balloon 22 via one or more openings through the elongatetubular body 14. For example, theinflation lumen 20 may terminate at an open distal end, or first distal opening, 26 of the elongatetubular body 14 that is in fluid communication with theinterior space 24 of thedilation balloon 22. - The elongate
tubular body 14 also defines acombination lumen 28 extending from theproximal end 16 to an open distal end, or second distal opening, 30 of the elongatetubular body 14. Thecombination lumen 28 may have various uses. For example, thecombination lumen 28 may be used for advancing theweeping balloon catheter 10 over awire guide 32 during a treatment procedure. Further, according to the present disclosure, thecombination lumen 28 may be used as an infusion pathway, as will be described below. - A
drug delivery balloon 34 may be disposed at least partially over thedilation balloon 22, according to a nested arrangement, and may include at least one drug release opening 36 through anouter wall 38 of thedrug delivery balloon 34. According to some embodiments, an array ofdrug release openings 36 may be provided. Thedrug delivery balloon 34 or, more particularly, an interior 40 of thedrug delivery balloon 34, is in fluid communication with thecombination lumen 28 through a sidewall opening 42 of the elongatetubular body 14. Although only asingle sidewall opening 42 is shown, it should be appreciated that additional fluid connections between thecombination lumen 28 and theinterior 40 of thedrug delivery balloon 34 may be provided. - A
proximal fitting 44 may provide an interface for communicating with one or both of theinflation lumen 20 and thecombination lumen 28, in a manner known to those skilled in the art. For example, theproximal fitting 44 may include two separate openings that are both in fluid communication with thecombination lumen 28. A first sealedopening 46 may include asealing member 48 and may be configured for receiving thewire guide 32, and a second selectively actuatedopening 50 may be configured for receiving a therapeutic agent. For example, a clamp, valve, or othersimilar member 52 may be provided for fluidly opening or closing a fluid connection between the second selectively actuatedopening 50 and thecombination lumen 28. - The
wire guide 32 may be received within thecombination lumen 28 during advancement of thecombination lumen 28 over thewire guide 32. A liquid source may be fluidly connected with theproximal fitting 44 and may provide a liquid, such as a therapeutic agent, through the second selectively actuatedopening 50 and along a drug delivery path defined by afirst clearance 54 between thewire guide 32 and awall 56 of thecombination lumen 28 and thedrug delivery balloon 34. Leakage at thefirst opening 46 may be reduced using the sealingmember 48. As should be appreciated, the drug delivery path, which is depicted inFIG. 9 and discussed below, also includes thesidewall opening 42 of the elongatetubular body 14. - The
proximal fitting 44 may include anadditional opening 58 for advancement of a fluid from a fluid source, through theinflation lumen 20, and into thedilation balloon 22. In particular, a desirable inflation medium may be advanced through theadditional opening 58, through theinflation lumen 20, through the opendistal end 26, and into theinterior space 24 of thedilation balloon 20. The fluid may transition thedilation balloon 22 from a collapsed state to an expanded state, in a manner known to those skilled in the art. - As shown, the
sidewall opening 42 may be proximal to thedilation balloon 22, for reasons that will become more apparent below. In addition, thesidewall opening 42 may be proximal to atransition 60 of thecatheter 12 from a dual lumen catheter, or catheter portion, 62 to a single lumen catheter, or catheter portion, 64. The duallumen catheter portion 62 may correspond to aproximal portion 66 of thecatheter 12, while the singlelumen catheter portion 64 may correspond to adistal portion 68 of thecatheter 12. The singlelumen catheter portion 64 may correspond in length with the portion of thecatheter 12 supporting thedilation balloon 22 and, as such, the singlelumen catheter portion 64 may be much shorter in length than the duallumen catheter portion 62. According to some embodiments, no more than two lumens (i.e., theinflation lumen 20 and the combination lumen 28) may be provided. In other words, the duallumen catheter portion 62 may include exactly two lumens including theinflation lumen 20 and thecombination lumen 28. - Turning now to
FIG. 2 , which depicts a cross section taken along lines 2-2 ofFIG. 1 , the duallumen catheter portion 62 may include theinflation lumen 20 and thecombination lumen 28 arranged in a side-by-side configuration. According to this exemplary embodiment, theinflation lumen 20 may have a crescent shape, while thecombination lumen 28 may have a substantially oval shape. The oval shape may provide additional clearance, shown at 80, on opposing sides of axis A. In particular, when thewire guide 32, which typically will have a cylindrical shape, is received within thecombination lumen 28, the additional clearance at 80 makes up a majority of thefirst clearance 54. Of course, alternative shapes and configurations of theinflation lumen 20 and thecombination lumen 28 are contemplated. -
FIG. 3 depicts a cross section taken along lines 3-3 ofFIG. 1 and represents the singlelumen catheter portion 64 of the weepingballoon catheter 10. According to some embodiments, adistal segment 90 of thecatheter 12, corresponding to the singlelumen catheter portion 64 of thecatheter 12, may have a reducedclearance 92, shown inFIG. 4 , between thewire guide 32 and thewall 56 of thecombination lumen 28 that is less than thefirst clearance 54. For example, in an expanded state of thedilation balloon 22, thedilation balloon 22 may radially, or inwardly, compress thewall 56 of thecombination lumen 28 to define the reducedclearance 92. Thedistal segment 90, which includes the reducedclearance 92, may be positioned between thesidewall opening 42 and the opendistal end 30. This reducedclearance 92 may reduce leakage through the opendistal end 30. - According to alternative embodiments, and as shown in
FIG. 5 , a duallumen catheter portion 100, which may be substituted for the duallumen catheter portion 62 described above, may include aninflation lumen 102 and acombination lumen 104 arranged in a coaxial configuration. For example, awall 106 defining thecombination lumen 104 may be non-circular or star-shaped, as shown, and may be configured for receiving awire guide 108 therethrough. According to some embodiments, aclearance 109 between thewall 106 and thewire guide 108 may be increased by radially, or outwardly, expanding thewall 106 using a therapeutic agent, or other liquid, advanced through thecombination lumen 104. This increase in flow area and, as a result, flow rate of an infusion liquid through thecombination lumen 104 may occur if theinflation lumen 102 is not at a relatively high pressure or is at a negative pressure. - According to yet another embodiment of the present disclosure, shown in
FIG. 6 , a duallumen catheter portion 110 may include aninflation lumen 112 and a combination lumen 114 arranged in a side-by-side configuration. However, as opposed to the side-by-side configuration shown inFIG. 2 , the combination lumen 114 ofFIG. 6 may include abutting or overlappingcircular openings guide retention feature 120 for restricting movement of awire guide 122 relative to a highclearance infusion area 124 of the combination lumen 114. For example, a lowclearance infusion area 126 may receive thewire guide 122, while the highclearance infusion area 124 defines a primary infusion path of the combination lumen 114. The wireguide retention feature 120 may restrict movement of thewire guide 122 into the higher flow of the highclearance infusion area 124. - It should be appreciated that a variety of different shapes and/or configurations exist for the
inflation lumen 20 and thecombination lumen 28. In particular, thecombination lumen 28 may be designed to provide a desired clearance around thewire guide 32 that results in a desired flow rate of a liquid being advanced through thecombination lumen 28 and into thedrug delivery balloon 34. The duallumen catheter portion 62 and the singlelumen catheter portion 64 may or may not be separate extrusions. Further, thecombination lumen 28 may be different or similar along the duallumen catheter portion 62 and the singlelumen catheter portion 64. - Turning now to
FIG. 7 , a percutaneous vascular procedure using the weepingballoon catheter 10 will be discussed with reference to avascular structure 130 of a patient. Although avascular structure 130 is shown, the present disclosure may be applicable to alternative bodily structures and lumens. Thevascular structure 130, as should be appreciated, may include avessel wall 132 defining alumen 134. Although not shown, it should be appreciated that a clinician may first use an introducer to gain access to thevascular structure 130 in a known manner. Next, as shown inFIG. 7 , the weepingballoon catheter 10 may be inserted through the introducer, over thewire guide 32, and into thevascular structure 130. In particular, thecombination lumen 28 may be advanced over thewire guide 32 toward atarget site 136, which may represent an area of stenosis in thevascular structure 130. The weepingballoon catheter 10 may be advanced such that thedistal end 18 of the weepingballoon catheter 10 and, more particularly, thedilation balloon 22 and thedrug delivery balloon 34 are positioned at thetarget site 136. - The
wire guide 32 may remain in position and, at a next stage of the procedure shown inFIG. 8 , thedilation balloon 22 may be inflated to an expanded state by advancing an inflation fluid, or other media, through theinflation lumen 20. The expanded state of thedilation balloon 22 may, according to some embodiments, press outwardly against thevessel wall 132 to widen thelumen 134 at thetarget site 136. Further, as described above, the expanded state of thedilation balloon 22 may radially compress thewall 56 of thecombination lumen 28 to define the reducedclearance 92, shown inFIG. 4 . - With the
dilation balloon 22 in the expanded state, a therapeutic agent, or other liquid, may be advanced along adrug delivery path 138 defined by thefirst clearance 54 between thewire guide 32 and thewall 56 of thecombination lumen 28 and thedrug delivery balloon 34, as shown inFIG. 9 . In particular, the therapeutic agent may be advanced through thecombination lumen 28 around thewire guide 32 and into thedrug delivery balloon 34 through thesidewall opening 42. According to some embodiments, thesidewall opening 42 may be positioned proximal to the reducedclearance 92. That is, thesidewall opening 42 may, according to some embodiments, be positioned proximal to thedilation balloon 22 and/or thetransition 60 of thecatheter 12 from thedual lumen catheter 62 to thesingle lumen catheter 64. - In some cases, leakage of the therapeutic agent through the open
distal end 30 may be reduced using the reducedclearance 92 described herein. It should be appreciated that the reducedclearance 92 may be pre-formed or may be provided dynamically, such as by inflation of thedilation balloon 22, as described above. However, it should be noted that inflation of thedilation balloon 22 is not required for infusion. Further, it should be noted that the reducedclearance 92 may not be required. Thesidewall opening 42 may be configured such that a majority of the therapeutic agent, or alternative liquid, flows from thefirst clearance 54 into thedrug delivery balloon 34. Ultimately, the therapeutic agent may be released from thedrug delivery balloon 34 throughdrug release openings 36 at thetarget site 136. - The shape and/or configuration of the
combination lumen 28 may be varied depending on the performance characteristics desired. For example, as shown inFIG. 2 , theinflation lumen 20 and the combinationmedical device lumen 28 may be provided in a side-by-side configuration, and the combination medial device andinfusion lumen 28 may have an oval shape to provideadditional clearance 80 at opposing sides of thewire guide 32. According to another side-by-side configuration, as shown inFIG. 6 , the combination lumen 114 may include abutting or overlappingcircular openings guide retention feature 120 for restricting movement of awire guide 122 relative to the highclearance infusion area 124. According to a coaxial configuration ofFIG. 5 , theclearance 109 between thewall 106 and thewire guide 108 may be increased by radially, or outwardly, expanding thewall 106 using a therapeutic agent, or other liquid, advanced through thecombination lumen 104. - As an alternative to the use of the
standard wire guide 32 described above, a specialty wire may be used as a substitute for, or in addition to, thestandard wire guide 32. For example, as shown inFIG. 10 , afirst specialty wire 140 may be sized for receipt within thecombination lumen 28 and may include a hollowtubular body 142. The hollowtubular body 142 may define adrug delivery path 144 extending from an openproximal end 146 to one ormore side openings 148 and may have a closeddistal end 150. When thespecialty wire 140 is received within thecombination lumen 28, the one ormore side openings 148 may be substantially aligned with the one ormore sidewall openings 42. As such, a liquid source may be fluidly connected to the openproximal end 146 to deliver a liquid, such as a therapeutic agent, through the hollowtubular body 142, through alignedopenings drug delivery balloon 34. Use of thespecialty wire 140 defining thedrug delivery path 144 and having the closeddistal end 150 may reduce leakage through the opendistal end 30 of thecatheter 12, particularly with minimal clearance between thespecialty wire 140 andwall 56 at theopenings - An alternative specialty wire that may be used with the weeping
balloon catheter 10 disclosed herein is shown at 160 inFIG. 11 . Thespecialty wire 160 may be used instead of thestandard wire guide 32 and may define a drug delivery path between thespecialty wire 160 and thewall 56 similar to that described above with respect to thestandard wire guide 32. Aproximal segment 162 of thespecialty wire 160 may have a profile, or diameter, that is less than that of thestandard wire guide 32 to define thefirst clearance 54 described above. Theproximal segment 162 may transition to adistal segment 164 having an increased profile, or diameter, which may be similar to that of thestandard wire guide 32. When thespecialty wire 160 is received within thecombination lumen 28, the transition between the proximal anddistal segments side opening 42. According to some embodiments, thedistal segment 164 may define the reducedclearance 92 described above. As such, leakage through the opendistal end 30 of thecatheter 12 may be reduced. - The weeping balloon catheter of the present disclosure permits a lower profile than conventional weeping balloon catheters. In particular, the disclosed weeping balloon catheter utilizes a common lumen for receiving a wire guide and advancing, or infusing, a therapeutic agent. In particular, according to some embodiments, the drug delivery path may be defined by a clearance between the wire guide and the wall defining the combination lumen. An additional advantage may include a simplification of the manufacturing process, since only two lumens are required at the dual lumen catheter portion of the weeping balloon catheter. Further, by infusing around the wire guide, and without requiring flushing of a conventional infusion lumen, procedure time and complexity may be reduced.
- It should be understood that the above description is intended for illustrative purposes only, and is not intended to limit the scope of the present disclosure in any way. Thus, those skilled in the art will appreciate that other aspects of the disclosure can be obtained from a study of the drawings, the disclosure and the appended claims.
Claims (20)
1. A weeping balloon catheter comprising:
a catheter having an elongate tubular body that defines exactly two lumens, and a first lumen of the exactly two lumens terminates at an open distal end of the elongate tubular body;
a dilation balloon mounted on the elongate tubular body and in fluid communication with one of the exactly two lumens;
a drug delivery balloon disposed at least partially over the dilation balloon and including at least one drug release opening through an outer wall of the drug delivery balloon, and the drug delivery balloon being in fluid communication with an other one of the exactly two lumens.
2. The weeping balloon catheter of claim 1 wherein the first lumen is the other one of the exactly two lumens in fluid communication with the drug delivery balloon.
3. The weeping balloon catheter of claim 1 including a wire guide positioned in the first lumen.
4. The weeping balloon catheter of claim 3 wherein the wire guide includes a distal segment extending distally from the open distal end of the elongate tubular body; and a proximal segment positioned in the first lumen; and
at least a portion of the distal segment has a larger diameter than the proximal segment positioned in the first lumen.
5. The weeping balloon catheter of claim 3 wherein the wire guide has a hollow interior that defines a portion of an infusion pathway.
6. The weeping balloon catheter of claim 1 wherein the first lumen is the other one of the exactly two lumens in fluid communication with the drug delivery balloon;
a wire guide positioned in the first lumen; and
a seal connected to a proximal segment of the elongate tubular body and being in sealing contact with the wire guide.
7. A weeping balloon catheter comprising:
a catheter having an elongate tubular body that defines an inflation lumen and a combination lumen;
a dilation balloon mounted on the elongate tubular body in fluid communication with the inflation lumen;
a drug delivery balloon disposed at least partially over the dilation balloon and including at least one drug release opening through an outer wall of the drug delivery balloon, and the drug delivery balloon being in fluid communication with the combination lumen; and
a wire guide received in the combination lumen;
wherein the wire guide at least partially defines an infusion path to the drug delivery balloon, and the wire guide at least partially defines a reduced clearance distally from the infusion path to reduce leakage of a liquid from the infusion path out of an open distal end of the combination lumen.
8. The weeping balloon catheter of claim 7 wherein the wire guide includes a distal segment extending distally from the open distal end of the elongate tubular body; and a proximal segment positioned in the combination lumen; and
at least a portion of the distal segment has a larger diameter than the proximal segment positioned in the combination lumen.
9. The weeping balloon catheter of claim 8 including a seal connected to a proximal segment of the elongate tubular body and being in sealing contact with the wire guide.
10. The weeping balloon catheter of claim 9 wherein the infusion path is defined partially by an outer surface of the wire guide.
11. The weeping balloon catheter of claim 7 wherein the wire guide has a hollow interior that defines a segment of the infusion path.
12. The weeping balloon catheter assembly of claim 7 wherein a segment of the infusion path is a side port defined by the elongate tubular body and fluidly connecting the combination lumen to the drug delivery balloon.
13. A method of delivering a liquid to a target site, comprising the steps of:
sliding a weeping balloon catheter over a wire guide to the target site;
inflating a dilation balloon of the weeping balloon catheter; and
moving a liquid along a surface of the wire guide, into a drug delivery balloon of the weeping balloon catheter, and to the target site through a drug release opening through an outer wall of the drug delivery balloon.
14. The method of claim 13 wherein the wire guide is received in a combination lumen of the weeping balloon catheter;
reducing leakage of the liquid through an open distal end of the combination lumen with an interaction between the wire guide and a distal segment of the weeping balloon catheter.
15. The method of claim 13 wherein the moving step includes moving the liquid along an outer surface of the wire guide.
16. The method of claim 13 wherein the wire guide is received in a combination lumen of the weeping balloon catheter;
wherein the wire guide includes a distal segment extending distally from the open distal end of the combination lumen, and a proximal segment positioned in the combination lumen; and
at least a portion of the distal segment has a larger diameter than the proximal segment positioned in the combination lumen.
17. The method of claim 13 wherein the inflating step is performed prior to the moving step.
18. The method of claim 17 wherein the moving step includes moving the liquid along an outer surface of the wire guide;
the wire guide is received in a combination lumen of the weeping balloon catheter;
wherein the wire guide includes a distal segment extending distally from the open distal end of the combination lumen, and a proximal segment positioned in the combination lumen; and
at least a portion of the distal segment has a larger diameter than the proximal segment positioned in the combination lumen.
19. The method of claim 18 wherein the moving step includes moving the liquid from the combination lumen, through a side port and into the drug delivery balloon.
20. The method of claim 19 including a step of contacting a seal with the wire guide at a proximal fitting of the weeping balloon catheter.
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US14/680,134 US20150209559A1 (en) | 2013-07-01 | 2015-04-07 | Weeping balloon catheter with drug delivery balloon in fluid communication with combination lumen |
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US201361841587P | 2013-07-01 | 2013-07-01 | |
US14/257,250 US9028443B2 (en) | 2013-07-01 | 2014-04-21 | Weeping balloon catheter with drug delivery balloon in fluid communication with combination lumen |
US14/680,134 US20150209559A1 (en) | 2013-07-01 | 2015-04-07 | Weeping balloon catheter with drug delivery balloon in fluid communication with combination lumen |
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US8926508B2 (en) * | 2009-12-17 | 2015-01-06 | Covidien Lp | Access assembly with dual anchor and seal capabilities |
ITRM20110479A1 (en) * | 2011-09-09 | 2013-03-10 | O P A Medical S R L | GROUP FOR CIFOPLASTIC INTERVENTIONS |
US9028443B2 (en) * | 2013-07-01 | 2015-05-12 | Cook Medical Technologies Llc | Weeping balloon catheter with drug delivery balloon in fluid communication with combination lumen |
US10035003B2 (en) | 2013-09-30 | 2018-07-31 | Dennis L Steffen | Dual balloon dual syringe delivery device and method of use |
GB2522403B (en) * | 2013-12-17 | 2017-09-13 | Aslam Nasir Muhammed | Airway device with flexible divider |
GB2555360B (en) | 2013-12-17 | 2018-10-10 | Intersurgical Ag | Intubating Airway Device |
KR101556119B1 (en) | 2015-04-09 | 2015-10-01 | 주식회사 지에이치바이오 | Double balloon catheter electrode device for medical |
USD842456S1 (en) | 2015-12-15 | 2019-03-05 | Intersurgical Ag | Airway device |
JPWO2017111164A1 (en) * | 2015-12-24 | 2018-10-18 | 日本ゼオン株式会社 | Endoscopic treatment tool |
US10350395B2 (en) | 2017-06-23 | 2019-07-16 | Cook Medical Technologies Llc | Introducer for lumen support or dilation |
GB201720733D0 (en) | 2017-12-13 | 2018-01-24 | Ashkal Development Ltd | Airway device |
US11426298B2 (en) * | 2019-07-31 | 2022-08-30 | Alucent Biomedical, Inc. | Apparatus and methods for restoring tissue |
CN110464405A (en) * | 2019-08-01 | 2019-11-19 | 江苏义倍医疗科技股份有限公司 | A kind of Multifunctional triangle balloon-stent easy to operate |
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US9028443B2 (en) | 2015-05-12 |
US20150005743A1 (en) | 2015-01-01 |
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